Catalog Number

01.60.70.10

Brand Name

Plan 1 Health

Version/Model Number

01.60.70.10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KMK

Product Code Name

Device, Intravascular Catheter Securement

Public Device Record Key

b8130dc6-3713-41b7-8ae3-fab89f70d85d

Public Version Date

October 26, 2022

Public Version Number

1

DI Record Publish Date

October 18, 2022

Package DI Number

10618125143860

Quantity per Package

2000

Contains DI Package

00618125143863

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box